Pharma COVID Roundup: News from Lilly, GSK, AstraZeneca, NovartisBy
The latest on manufacturing and potential treatments for COVID-19 with news from CSL, Regeneron, Lilly, AstraZeneca, Novartis, GSK, Novavax, CSL, Moderna, and others.
Manufacturing and supply of COVID-19 vaccines and drugs
CSL Begins Manufacturing AstraZeneca’s COVID-19 Vaccine
CSL reports it will begin manufacturing AstraZeneca’s COVID-19 vaccine candidate, AZD1222, at its manufacturing facility in Broadmeadows, Victoria, Australia.
CSL has separate contracts with AstraZeneca and the Australian government to manufacture approximately 30 million doses of AZD1222, with the first doses planned for release in the first half of 2021, pending the outcome of clinical trials and regulatory approval.
The manufacturing process will start with the thaw of vials containing vaccine cells. The vial- thaw milestone follows several months of collaboration and preparation by CSL and AstraZeneca technical experts. During 2020/2021, CSL will manufacture eight large-scale batches of the vaccine drug substance. Should the vaccine demonstrate its safety and efficacy in current clinical trials, it is anticipated that it will require a two-dose-per-person regime.
The vaccine will not be released for use until the relevant clinical trial and manufacturing data are reviewed and approved by the Australian regulatory authority, the Therapeutic Goods Administration.
Regeneron Ramps Up Production of COVID-19 Antibody Cocktail
Regeneron Pharmaceuticals, a Tarrytown, New York-based biopharmaceutical company, has reported it continues to ramp up production of its investigational antibody cocktail, REGN-COV2, and now expects to have approximately 80,000 doses available by the end of November (November 2020).
In addition, Regeneron says it expects to have approximately 200,000 total doses ready by the first week of January 2021 and approximately 300,000 total doses ready by the end of January 2021.
REGN-COV2 is a combination of two monoclonal antibodies (REGN10933 and REGN10987) and was designed to block infectivity of SARS-CoV-2, the virus that causes COVID-19.
Earlier this month (November 2020), Regeneron received a recommendation from an independent data monitoring committee to hold enrollment for one patient group of its clinical trials for REGN-COV2. The trial was evaluating REGN-COV2 in hospitalized COVID-19 patients requiring high-flow oxygen or mechanical ventilation. Other studies continue.
Updates on COVID-19 treatments and vaccines
FDA OKs Emergency Use for Lilly’s COVID-19 mAb Candidate
The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to Eli Lilly and Company’s investigational neutralizing antibody, bamlanivimab, for treating mild-to-moderate COVID-19 in adult and pediatric patients.
An EUA is intended to provide availability of a medicine during an emergency; an EUA is not the equivalent of an FDA approval. The authorization allows for the distribution and emergency use of bamlanivimab, which is administered via a single intravenous infusion.
The US Department of Health and Human Services (HHS) has announced plans to allocate initial doses of bamlanivimab using a data-driven system to ensure continued fair and equitable distribution. Beginning immediately (as reported on November 10, 2020), weekly allocations to state and territorial health departments will be proportionally based on confirmed COVID-19 cases in each state and territory over the previous seven days based on data hospitals and state health departments enter into the HHS Protect data-collection platform.
Lilly will begin shipping bamlanivimab to AmerisourceBergen, which will distribute it as directed by the US government’s allocation program. The US government has purchased 300,000 doses of bamlanivimab.
Lilly has invested in large-scale manufacturing of bamlanivimab at risk. Lilly says it anticipates manufacturing up to one million doses of bamlanivimab (700 mg) by the end of 2020 for use globally through early next year. Beginning in the first quarter of 2021, the supply is expected to increase as additional manufacturing resources come on line throughout the year.
Novavax COVID-19 Vaccine Fast-Tracked by FDA
Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, has received US Food and Drug Administration (FDA) fast-track designation for NVX-CoV2373, its COVID-19 vaccine candidate.
Novavax says it expects to begin a Phase III clinical trial in the US and Mexico by the end of November (November 2020). Data from trial could support global authorization and approval, including in the US. The company’s ongoing Phase III clinical trial in the UK to evaluate NVX-CoV2373 is expected to be fully enrolled by the end of November (November 2020). Interim data are expected early in the first quarter of 2021, dependent on the overall COVID-19 attack rate.
AstraZeneca’s Calquence Shows Disappointing Results in COVID-19 Trials
AstraZeneca reports that its drug, Calquence (acalabrutinib), which is being developed to treat multiple B-cell blood cancers, did not meet the primary efficacy endpoint in Phase II trials in patients hospitalized with respiratory symptoms of COVID-19.
AstraZeneca says the addition of Calquence to best supportive care (BSC) did not increase the proportion of patients who remained alive and free of respiratory failure. No new safety signal for Calquence was observed in the trials. The program comprised two Phase II trials investigating acalabrutinib plus BSC versus BSC alone in hospitalized patients with COVID-19. The safety and tolerability profiles for Calquence in the Phase II trials were consistent with previous trials.
Novartis Reports Disappointing Results of Cardio Drug for COVID-19
Novartis reports disappointing results from a Phase III study of canakinumab, a drug to treat arthritis and other autoimmune diseases, being evaluated in hospitalized patients with COVID-19 pneumonia and cytokine release syndrome.
The drug failed to meet its primary endpoint and showed that treatment with canakinumab plus standard of care (SoC) did not demonstrate a greater chance of survival for patients without the need for invasive mechanical ventilation.
The company also reports that the trial did not meet its key secondary endpoint of reducing the COVID-19-related death rate during the fur-week period after treatment.
GSK, Medicago Start Phase II/III Trials for Plant-Derived COVID-19 Vaccine
GlaxoSmithKline (GSK) and Medicago, a Quebec-based biopharmaceutical company, have started Phase II/III clinical trials of a plant-derived vaccine candidate for COVID-19. The vaccine combines Medicago’s recombinant coronavirus virus-like particles (CoVLP) with GSK’s pandemic adjuvant system.
In early July (July 2020), GSK and Medicago formed a collaboration to develop and evaluate the COVID-19 candidate vaccine.
Brazilian Ministry of Health Resumes Sinovac Phase III COVID Vaccine Trial
The Brazilian National Health Surveillance Agency (ANVISA) has authorized the resumption of the Phase III clinical trial of CoronaVac, a COVID-19 vaccine candidate of Sinovac, a Beijing, China-based biopharmaceutical company, and Instituto Butantan, a Brazilian biologic research center.
The trial was interrupted by ANVISA due to the occurrence of a serious adverse event on October 29, 2020. On November 10, 2020, Sinovac reported that after communicating with its partner, Instituto Butantan, the company believed that this serious adverse event was not related to the vaccine.
CoronaVac, being developed by Instituto Butantan and Sinovac, is in the final stage of clinical testing, which when finalized, will be submitted for approval and registration to ANVISA. After authorization from ANVISA, Instituto Butantan says it will receive the first 120,000 doses of CoronaVac with arrival scheduled for November 20, 2020.
In a separate development, the Instituto Butantan began working on a new facility to manufacturing CoronaVac, with a production capacity of 100 million doses per year. The company says the plant will be built with donations from the private sector.
The new plant will have about capacity of 10,000 m² and in addition to producing doses of the vaccine against COVID-19, it will be able to produce other immunizers manufactured at the Butantan Institute. The facility is expected to be completed in up to 10 months (as reported on November 9, 2020), at a cost of BRL $160 million ($30 million).
Moderna Completes Case Accrual for Interim Analysis of COVID-19 Vaccine
Moderna, a clinical-stage biopharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, has completed case accrual for the first interim analysis of the Phase III study of mRNA-1273, its COVID-19 vaccine candidate.
Moderna says it has seen a significant increase in the rate of case identification across sites in the last week (as reported on November 11, 2020). As a result, the company expects the first interim analysis will include substantially more than 53 cases, the targeted trigger point for the analysis. The data on these cases is being prepared for submission to the Independent Data Safety Monitoring Board (DSMB) for analysis and recommendation. Moderna remains blinded to whether these participants received vaccine or placebo.
Late last month (October 2020), the Phase III completed enrollment of 30,000 participants in the US. The study was designed in collaboration with the US Food and Drug Administration and the National Institutes of Health.
NIH Reports Hydroxychloroquine Does Not Benefit Patients with COVID-19
The National Institutes of Health (NIH) reports that hydroxychloroquine, a drug approved for treating malaria, lupus, and rheumatoid arthritis and being evaluated to treat COVID-19, provides no clinical benefit to hospitalized patients.
The NIH had stopped a clinical trial of the drug in June (June 2020) due to the drug showing that it was not improving outcomes in COVID-19 patients. Final data and analyses of the trial, which was funded by the National Heart, Lung, and Blood Institute (NHLBI), part of NIH, will appear online in the Journal of the American Medical Association.
Source: National Institutes of Health
News on COVID-19 testing
GenScript Gets EUA for SARS-CoV-2 Neutralizing Antibody Detection Kit
GenScript USA, a Piscataway, New Jersey-based research reagent provider, has been granted emergency use authorization (EUA) by the US Food and Drug Administration (FDA) for its SARS-CoV-2 neutralization antibody detection kit.
The cPass SARS-CoV-2 Neutralization Antibody Detection Kit detects neutralizing antibodies without the use of live virus. The test measures the presence of neutralizing antibodies in any sample, from those from patients recovering from COVID-19 or those vaccinated against SARS-CoV-2, the virus that causes COVID-19.
The company says detection of the presence of neutralizing antibodies can be performed in most standard research or clinical diagnostic laboratories with short turnaround time. Furthermore, GenScript says a comparison of the direct clinical performance between the conventional live virus and the cPass assay shows results from both tests are strongly correlated.